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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Impactions
Scientific title
The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Oesophageal Impactions
Secondary ID [1] 289613 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft food bolus impaction 299399 0
Condition category
Condition code
Oral and Gastrointestinal 299381 299381 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Glucagon 2mg intravenous + Glyceryl trinitrate 600mg orally administered simultaneously as a single administration

No strategy to monitor adherence is necessary as drugs will be administered by trained nursing staff.
Intervention code [1] 295221 0
Treatment: Drugs
Comparator / control treatment
Intravenous normal saline + glucose disintegrating placebo tablet orally
Control group

Primary outcome [1] 298844 0
Clinical resolution of impaction by 30 minutes post administration of drugs as defined by:
a. Ability to tolerate food and fluids without regurgitation
b. No regurgitation of secretions
c. Clinical gestalt of senior ED doctor
Timepoint [1] 298844 0
30 minutes from administration of drug
Secondary outcome [1] 325390 0
Endoscopy rate which will be calculated by checking each participant's medical record for endoscopy records
Timepoint [1] 325390 0
48 hours post first presentation to the ED
Secondary outcome [2] 325391 0
Evidence of oesophageal pathology whether by direct visualisation on endoscopy or subsequent histopathological examination of biopsy specimens
Timepoint [2] 325391 0
3 months post first presentation to the ED

Key inclusion criteria
a. Patients with first presentation of soft food bolus impaction
b. Patients above or equal to 18 years old
c. Patients capable of furnishing informed consent
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
a. Known oesophageal malignancy or structural abnormalities
b. Previous presentation with soft food bolus oesophageal impaction
c. Known allergy or intolerance to glucagon or GTN
d. Extrinsic or intrinsic airway compromise
e. Oesophageal impaction with inedible or hard foods (e.g. bones, pills, nails)
f. Preload dependent cardiovascular physiology (e.g. severe aortic stenosis, hypotension)
g. Known insulinoma, pheochromocytoma or glucagonoma

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Manual shuffling of envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis
Sample size of 580 required to demonstrate non-inferiority of drugs regimen with placebo with an alpha of 10% and a beta of 80% assuming a control success rate of 8% and a non-inferiority limit of 5%. The control success rate is based on retrospective data generated from the same state.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 6111 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 6112 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 6113 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 293992 0
Self funded/Unfunded
Name [1] 293992 0
Alwin Lian
Address [1] 293992 0
Royal Perth Hospital
197 Wellington Street
Perth 6000 WA
Country [1] 293992 0
Funding source category [2] 293993 0
Self funded/Unfunded
Name [2] 293993 0
Richard Holman
Address [2] 293993 0
Fiona Stanley Hospital
11 Robin Warren Drive,
Murdoch 6150 WA
Country [2] 293993 0
Funding source category [3] 293994 0
Name [3] 293994 0
Royal Perth Hospital
Address [3] 293994 0
197 Wellington Street
Perth WA 6000
Country [3] 293994 0
Funding source category [4] 293995 0
Name [4] 293995 0
Fiona Stanley Hospital
Address [4] 293995 0
11 Robin Warren Drive
Murdoch WA 6150
Country [4] 293995 0
Funding source category [5] 293996 0
Name [5] 293996 0
Sir Charles Gairdner Hospital
Address [5] 293996 0
Hospital Ave
Nedlands WA 6009
Country [5] 293996 0
Primary sponsor type
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA 6150
Secondary sponsor category [1] 292810 0
Name [1] 292810 0
Address [1] 292810 0
Country [1] 292810 0

Ethics approval
Ethics application status
Ethics committee name [1] 295408 0
Royal Perth Hospital HREC
Ethics committee address [1] 295408 0
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Ethics committee country [1] 295408 0
Date submitted for ethics approval [1] 295408 0
Approval date [1] 295408 0
Ethics approval number [1] 295408 0

Brief summary
The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus.

Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable

In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 67198 0
Dr Alwin Lian
Address 67198 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67198 0
Phone 67198 0
Fax 67198 0
Email 67198 0
Contact person for public queries
Name 67199 0
Dr Alwin Lian
Address 67199 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67199 0
Phone 67199 0
Fax 67199 0
Email 67199 0
Contact person for scientific queries
Name 67200 0
Dr Alwin Lian
Address 67200 0
c/o RPH
Wellington Street
Perth WA 6000
Country 67200 0
Phone 67200 0
Fax 67200 0
Email 67200 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Not likely to be useful
What supporting documents are/will be available?
No other documents available
Summary results
No Results